A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Duliang Soft Capsule in Patients with Chronic Daily Headache
Joint Authors
Yu, Shengyuan
Hu, Yueqing
Wan, Qi
Zhou, Jiying
Liu, Xinfeng
Qiao, Xiangyang
Yang, Xiaosu
Feng, Jiachun
Chen, Kangning
Pan, Xiaoping
Yang, Qingwu
Dou, Linsen
Liu, Ming
Chen, Yangmei
Yu, Tingmin
Yu, Juming
Li, Zhiwei
Bai, Xue
Duan, Jingfeng
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-05-26
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Objective.
To investigate the efficacy and safety of traditional Chinese medicine Duliang soft capsule (DSC) in prophylactic treatment for patients with chronic daily headache (CDH).
Methods.
A multicenter, double-blind, randomized, placebo-controlled clinical study was conducted at 18 Chinese clinical centers.
The participants received either DSC or placebo for 4 weeks.
The primary efficacy measure was headache-free rate (HFR) in a 4-week period between the pretreatment and posttreatment stages.
The secondary efficacy measures were the decrease of headache days, the duration of headache attacks, the frequency of analgesic usage, quality of life, disability, and the headache severity (VAS scores).
The accompanying symptoms and adverse events were also assessed.
Results.
Of 584 CDH patients assessed, 468 eligible patients were randomized.
338 patients received DSC, while 111 patients were assigned in the placebo group.
Following treatment, there was a 16.56% difference in HFR favoring DSC over placebo ( P < 0.01 ).
Significant differences were also observed between DSC and placebo groups in the secondary measures.
However, no statistical difference was found between the two groups in the associated symptoms.
No severe adverse effects were observed in the study.
Conclusions.
DSC might be an effective and well-tolerated option for the prophylactic treatment of patients with CDH.
American Psychological Association (APA)
Yu, Shengyuan& Hu, Yueqing& Wan, Qi& Zhou, Jiying& Liu, Xinfeng& Qiao, Xiangyang…[et al.]. 2015. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Duliang Soft Capsule in Patients with Chronic Daily Headache. Evidence-Based Complementary and Alternative Medicine،Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1063472
Modern Language Association (MLA)
Yu, Shengyuan…[et al.]. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Duliang Soft Capsule in Patients with Chronic Daily Headache. Evidence-Based Complementary and Alternative Medicine No. 2015 (2015), pp.1-8.
https://search.emarefa.net/detail/BIM-1063472
American Medical Association (AMA)
Yu, Shengyuan& Hu, Yueqing& Wan, Qi& Zhou, Jiying& Liu, Xinfeng& Qiao, Xiangyang…[et al.]. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Duliang Soft Capsule in Patients with Chronic Daily Headache. Evidence-Based Complementary and Alternative Medicine. 2015. Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1063472
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1063472